Metadata used in the bibliometric analysis.

Background
Decision impact studies have become increasingly prevalent in genomic medicine, particularly in cancer research. Such studies are designed to provide evidence of clinical utility for genomic tests by evaluating their impact on clinical decision-making. This paper offers insights into understanding of the origins and intentions of these studies through an analysis of the actors and institutions responsible for the production of this new type of evidence.
Methods
We conducted bibliometric and funding analyses of decision impact studies in genomic medicine research. We searched databases from inception to June 2022. The datasets used were primarily from Web of Science. Biblioshiny, additional R-based applications, and Microsoft Excel were used for publication, co-authorship and co-word analyses.
Results
163 publications were included for the bibliometric analysis; a subset of 125 studies were included for the funding analysis. Included publications started in 2010 and increased steadily over time. Decision impact studies were primarily produced for proprietary genomic assays for use in cancer care. The author and affiliate analyses reveal that these studies were produced by ‘invisible colleges’ of researchers and industry actors with collaborations focused on producing evidence for proprietary assays. Most authors had an industry affiliation, and the majority of studies were funded by industry. While studies were conducted in 22 countries, the majority had at least one author from the USA.
Discussion
This study is a critical step in understanding the role of industry in the production of new types of research. Based on the data collected, we conclude that decision impact studies are industry-conceived and -produced evidence. The findings of this study demonstrate the depth of industry involvement and highlight a need for further research into the use of these studies in decision-making for coverage and reimbursement.

研究背景
决策影响研究在基因组医学领域，尤其是癌症研究中愈发普及。此类研究旨在通过评估基因组检测对临床决策的影响，为其临床效用提供证据支撑。本文通过分析负责生成这类新型证据的主体与机构，加深学界对这类研究的起源与初衷的理解。

研究方法
本研究针对基因组医学研究中的决策影响研究开展文献计量与资助分析。我们检索了各数据库自建库至2022年6月的相关文献，数据集主要来源于科学引文索引（Web of Science）。研究采用Biblioshiny、其他基于R的应用程序以及Microsoft Excel开展文献发表量、合著与共词分析。

研究结果
本次文献计量分析共纳入163篇文献，资助分析则纳入其中125项研究。纳入的相关文献始于2010年，且发文量随时间稳步增长。决策影响研究主要围绕用于癌症诊疗的专利基因组检测试剂盒（proprietary genomic assays）展开。作者与机构关联分析显示，此类研究由研究者与行业主体组成的无形学术共同体完成，其合作聚焦于为专利基因组检测试剂盒生成证据。多数作者拥有行业机构的关联背景，且绝大多数研究由行业资助。尽管此类研究在22个国家开展，但大部分研究至少拥有一名来自美国的作者。

讨论
本研究是理解行业在新型研究生成过程中所扮演角色的关键一步。基于收集到的数据，我们得出结论：决策影响研究是由行业构思并开展的证据生成工作。本研究结果揭示了行业参与的深度，并强调亟需开展进一步研究，以探索此类研究在医保覆盖与费用报销决策中的应用价值。